To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
2 capsule 80 mg x 8 days
4 capsule 80 mg x 8 days
2 capsules of placebo x 8 days 4 capsules of placebo x 8 days
CIM-Sant Pau
Barcelona, Barcelona, Spain
Number of Participants with Serious and Non-Serious Adverse Events
Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed
Time frame: from day 0 to day 15
AUC
Day 1: baseline \[pre-dose\], \[+10 min\], \[+20 min\], \[+40min\], \[+60min\], \[+ 1.5h\], \[+2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+8h\], \[+ 12h\] and \[+16h\] post-medication; * Days 2 to 7: baseline \[daily pre-dose\] which corresponds at +24h of previous dose; * Day 8: baseline \[daily pre-dose\], \[+10 min\], \[+20 min\], \[+40min\], \[+60min\], \[+1.5h\], \[+2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+8h\], \[+ 12h\] and \[+16h\] and \[+ 24h\] post-daily medication (D9).
Time frame: from day 1 to 8
Cmax
Day 1: baseline \[pre-dose\], \[+10 min\], \[+20 min\], \[+40min\], \[+60min\], \[+ 1.5h\], \[+2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+8h\], \[+ 12h\] and \[+16h\] post-medication;
Time frame: from day 1 to 8
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